FDA-Drug2023-05-17Class III

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

The Harvard Drug Group
Hazard

Product mixup: one foreign tablet found in product.

Sold states
USA Nationwide
Affected count
3984 cartons
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2023

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